Senior Global Trial Specialist

Contributes to the operational execution of clinical studies to ensure delivery.
on time, within budget, and of high quality in compliance with ICH/GCP,.
Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs..
Participates on one or more cross-functional study team(s) and/or performance.
and quality oversight of one or more Contract Research Organization (CRO).
teams and vendors..
Primarily works on routine to complex projects/trials at varying stages and.
supports multiple complex trials as needed..
Contributes to achieving corporate and study team goals, successfully.
completes assigned tasks, participates in service provider oversight, and sets.
priorities with guidance..
Proactively manages multiple assignments and operational processes with.
moderate to minimal supervision..
Has high functional impact on the study team and the organization..
Disclaimer The responsibilities listed above are only a summary and other.
Duties/Responsibilities.
responsibilities will be requirements as assigned..
Involve a combination of execution and oversight, dependent.
on the sourcing model, to ensure deliverables and may include, but are not.
limited to the following.
Project Management.
Provides operational input and facilitates operational processes as an SME.
in support of the startup, maintenance, and closure of studies..
Uses performance metrics and quality indicators to assist the Global Trial.
Manager in driving study execution..
Proactively Identifies risks and develops/implements actions to avoid or.
mitigate..
Resolves routine problems and escalates important issues appropriately (with.
a sense of urgency)..
Actively contributes as a key functional member on cross-functional teams..
Study/Project Planning, Conduct and Management.
Provides and support input to study level tools and plans while working with.
moderate to minimal supervision..
Independently performs core GTS tasks and escalates/pushes.
back/delegates appropriately..
Actively contributes to study meetings by leading some components..
Contributes to oversight of the required country regulatory (e.g., CTA, MoH).
and country/site IRB/IEC approvals/notifications..
Flexibility to work on various trials at varying stages/complexity with minimal.guidance as needed..
Understands strategy and decision making at program level and their impact.
on the studies..
Ability to contribute to initiatives for process development and improvement..
Ability to assess a situation and identify path forward with the appropriate.
resources.
Qualifications Specific Knowledge, Skills, Abilities.
Understands interdependencies of tasks assigned..
Manages vendors and site payment processing and tracking..
Facilitate the maintenance of study budget tracking tools and reconciles.
invoices with overall contract/budget and finance reports..
Reporting Relationship Crossing all therapeutic areas and research phases, collaborate with cross[1]functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report..
Technical Competencies.
Knowledge of ICH/GCP, regulatory guidelines and directives, and the.
drug development process..
Knowledge of clinical research budgets including processing and tracking.
of site and vendor payments is preferred..
Working knowledge of project management preferred..
Management Competencies.
Begin to network and foster relationships with key stakeholders across.
the study team..
Responds flexibly to changing business demands and opportunities,.
proactively looking for ways to contribute..
Acts as a role model in supporting change within the organization and.
has knowledge of cross-functional partners who can help clarify change..
Mentors and coaches other team members and GTS', as appropriate,.
and participate or provide leadership in departmental initiatives..
Builds relationships to achieve influence with others..
Develops and maintains collaborative relationships with internal and.
external stakeholders to be more effective in the role..
Displays a willingness to challenge the status quo and take risks..
Effective oral/written communication and presentation skills, ability to.
collaborate with key stakeholders and across the organization..
Education/Experience/ Licenses/Certifications.
BA/BS in relevant discipline strongly preferred..
Minimum 1 years' experience in Clinical Research or related work.
experience..
Experience in the use of industry Clinical Trial Management Systems and.
Clinical Trial Master File Systems..
Travel required less than 5%..
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career..
Uniquely Interesting Work, Life-changing Careers.
With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary.